Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food

Healthy Individuals Clinical Trial

— Nutri-I-Food  

Official title:

Intervention Study With Crop Lettuce Enriched With Iodine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011968
• Other study ID #: Nutr-I-Food2019
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: August 2021
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the project is to study of the influence of Lettuce crop enriched with Iodine on Thyroid hormone synthesis. Secondary outcome to find out iodine presence in urine in order to evaluate vegetables, like little crop, as Iodine biocarrier

Description:

Several human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. An alternative or even complementary way is represented by the intake of bio-fortified foods. In the field of mineral deficiency increasing the bioavailable mineral concentration in vegetables intended for human consumption; can be a useful tool to prevent many harmful pathologies. Therefore, in this scenario, it appears very important to identify the right dosages and the most effective methods of administration to bio-fortify vegetables with a strong nutritional-health connotation.

The present project aim to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, healthy individuals received lettuce enriched with iodine and after 10 days plasma and urine samples were collected . Each subject was subjected to two venous blood samples taken at the beginning of the observation and at the end (after 10 days). The samples thus obtained were transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin,TSH, FT3, FT4, hematocrit, hs-CRP, Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 30, 2020
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Caucasian

• age: 18-65 years

• healthy status

• no drug therapy or integration therapy

Exclusion Criteria:

• Inflammatory chronic disease

• use of medication or suffering from any condition

• pregnancy

• breastfeeding

• current smokers

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Dietary Supplement:
• Lettuce with not biofortification
Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
• Lettuce biofortificated with Iodine
Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days

Locations

Country	Name	City	State
Italy	Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Thyroid markers	serum levels of free tri-iodothyronine (FT3 ng/L), free thyroxine (FT4 ng/L) and thyroid-stimulating hormone (TSH ng/L) will be assessed at baseline and after 10 days	10 days
Primary	Urine Iodine concentration	Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days	10 days
Primary	Haematology and serum chemistry values 1	glucose (mg/dL), albumin( mg/dL), total cholesterol (mg/dL), HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), triglycerides(mg/dL), uric acid(mg/dL), creatinine(mg/dL) will be assessed at baseline and after 10 days	10 days
Primary	Haematology and serum chemistry values 2	insulin (mUI/L) will be assessed at baseline and after 10 days	10 days
Primary	Haematology and serum chemistry values 3	Potassium (mmol/L) will be assessed at baseline and after 10 days	10 days
Primary	Haematology and serum chemistry values 4	Ferritin (mg/L), free Iron (mg/L), transferrin (mg/L), total proteins (mg/L), Magnesium (mg/L), Calcium (mg/L), Vitamin D (mg/L), HCRP (mg/L), Phosphate (mg/L), Cortisol (mg/L)will be assessed at baseline and after 10 days	10 days
Primary	Haematology and serum chemistry values 5	AST (U/L), ALT (U/L), ?-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days	10 days
Secondary	body mass index (BMI)	BMI (kg/m2) All these measurements will be assessed at baseline and after 10 days	10 days
Secondary	body composition (%)	lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days	10 days
Secondary	Gastric Hormones	GIP (pg/m), GLP1 (pg/m), GLP2 (pg/m), ghrelin (pg/m), glucagon (pg/m), PYY (pg/m), CCK(pg/m) measured in plasma will be assessed at baseline and after 10 days	10 days
Secondary	Oxidative stress markes	LDL-ox (ug/mL), AGE(ng/mL), urinary 8-iso-prostaglandin F (PGF)2alpha (ng/mL) will be assessed at baseline and after 10 days	10 days
Secondary	Bone metabolism	Osteocalcin(ng/L), parathyroid hormone (ng/L), CTX, Calcitonin (ng/L) measured in plasma will be assessed at baseline and after 10 days	10 days
Secondary	Inflammatory markers	IL-1 (pg/mL), TNF(pg/mL), IL-6(pg/mL), IL-10(pg/mL) measured in plasma will be assessed at baseline and after 10 days	10 days
Secondary	Weigh	Weight (Kg) will be assessed at baseline and after 10 days	10 days
Secondary	Hight	Hight (m) will be assessed at baseline and after 10 days	10 days